Senior Principal Specialist, Quality Assurance (Design)
Leica Biosystems
Miami, FL
9 days ago
Job Description
Join Leica Biosystems as a Senior Principal Specialist in Quality Assurance where you'll lead design control for innovative medical device projects. Collaborate with global teams to ensure high-quality products while mentoring the next generation of Quality Assurance professionals.
Key Responsibilities
Serve as Quality Assurance lead for Design Control covering business-critical new product development projects and external partnership programs
Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, Regulatory Affairs, Research and Development, Product and Program Management) to achieve project goals and meet timelines
Critically review and approve analytical and clinical study protocols and reports to assess quality, identify gaps, and provide mitigations
Define regulatory strategy and plans for clearance/approval of technologies intended for cancer diagnostics
Mentor and coach Quality Assurance professionals in their development
Required Qualifications
Extensive experience in medical device industry covering Innovation and Design Control
Proven experience supporting submissions for high-complexity diagnostic products in a global market, specifically 510(k) and PMA submissions in the USA
Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, and the MDSAP programme
Substantial experience in commercial product development including transfer of complex feasibility projects into product commercialization
Experience in support of New Product Development for high complexity products with experience supporting complex clinical trials and Pharma partner integration
Preferred Qualifications
Previous experience in the IVD, Companion Diagnostics, and/or stand-alone software/digital fields
Collaborating with external stakeholders, such as suppliers, and academia
FDA and EU requirements covering Design Control activities for IVDs and/or medical devices